FDA 510(k)

SafeAir Smoke Evacuator compact

Número K: K182224 · 2019-02-07

Data da decisão2019-02-07

Código do produtoFYD

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

SafeAir Smoke Evacuator compact is the device name listed in this FDA 510(k) record. The listed applicant is Lina Medical Aps. It received FDA 510(k) clearance on 2019-02-07 under 510(k) number K182224. The device is classified under product code FYD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SafeAir Smoke Evacuator compact?

SafeAir Smoke Evacuator compact is a medical device that received FDA 510(k) clearance on 2019-02-07. The listed applicant is Lina Medical Aps. The 510(k) number is K182224.

When did SafeAir Smoke Evacuator compact receive FDA 510(k) clearance?

SafeAir Smoke Evacuator compact received FDA 510(k) clearance on 2019-02-07, under 510(k) number K182224.

Who is the listed applicant for SafeAir Smoke Evacuator compact?

The FDA 510(k) record lists Lina Medical Aps as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SafeAir Smoke Evacuator compact?

The FDA product code for SafeAir Smoke Evacuator compact is FYD.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Outros registros que listam Lina Medical Aps como candidato(a)

K240227LiNA CystoVu™ HD (CYV-100-5; CYV-101-5); LiNA ScopeVu™ (SCP-100-1)K223932SafeAir combi (SFR-combi-US)K221085LiNA OperaScope Needle K193007LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module K182354SafeAir Telescopic Smoke Pencil K171113LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI cable and on-board LCD-6 units, LiNA OperaScope Recording Module

Ver todos os 7 dispositivos →

Dispositivos Relacionados (Código: FYD)

K240127PlumeSafe X5 Smoke Management SystemConmed Corporation K2337898Q10 Sistema de Evacuação de Fumaça de Névoa SurclearSurnic Corporation K213068Medline Smoke Evacuation ShroudMedline Industries, Inc.K202944NEBULAE SRS Laparoscopic Surgical Smoke Removal SystemNorthgate Technologies, Inc.K200250Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF SensorMegadyne Medical Products, Inc.K192035EvaQMax Smoke Evacuation SystemBio Protech, Inc.

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.